Anesthetic Effect Duration Assessment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT01545765
First received: February 24, 2012
Last updated: June 25, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to evaluate the duration of anesthetic effect produced , Lidocaine7% + Tetracaine 7% cream when applied with 2 different application times on the face and thigh.


Condition Intervention Phase
Healthy Volunteers
Drug: Lidocaine 7% + Tetracaine 7% cream
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Anesthetic Effect Duration Produced by Lidocaine 7% + Tetracaine 7% Cream on 2 Different Body Areas

Resource links provided by NLM:


Further study details as provided by Galderma:

Primary Outcome Measures:
  • Duration of Anesthesia(Minutes) [ Time Frame: From T0 (product removal) up to T8 hours after product removal ] [ Designated as safety issue: No ]
    Onset and end of anesthesia are evaluated by Pinprick tests. Duration of anesthesia is calculated as: difference between onset and end of anesthesia (minutes).


Secondary Outcome Measures:
  • Adverse Events [ Time Frame: During the study ] [ Designated as safety issue: Yes ]
    Incidence of adverse events was to be reported during the study period


Enrollment: 30
Study Start Date: May 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lidocaine 7% and tetracaine 7% Drug: Lidocaine 7% + Tetracaine 7% cream
Study drug will be applied with a different application time to one side of the face and anterior thigh according to the randomization list.

Detailed Description:

Subjects will have 4 target zones defined; 2 on the face and 2 on the anterior thighs. Upon inclusion into the study, subjects will have the study drug applied with a different application time to one side of the face and anterior thigh according to the randomization. After the completion of the application process, study drug on both sides of the face and on both anterior thighs will be removed by peeling.

After drug removal, the duration of anesthetic effect of the study drug will be tested using a pinprick test. Five (5) pinpricks using a 21-gauge needle will be performed at the 4 target zones (each side of the face and both anterior thighs). The pinprick test will be repeated up to 8 hours after drug removal. There will be a total of 20 post drug removal pinprick test completed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male of female subjects aged 18 or older with a normal not excessive hairy skin,

Exclusion Criteria:

  • Female subjects who are pregnant or breast-feeding; or plan to become pregnant,
  • Subjects who have a known allergy to one of the components of the test drug lidocaine, tetracaine or other local anesthetics,
  • Subjects who are at risk in terms of precautions, warnings, and contra-indication with the study product.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01545765

Locations
United States, New Jersey
Galderma Investigational center
Rochelle Park, New Jersey, United States
Sponsors and Collaborators
Galderma
Investigators
Principal Investigator: Regina YAVEL, MD- Dermatologist Galderma investigational center
  More Information

No publications provided

Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01545765     History of Changes
Other Study ID Numbers: RD.03.SPR29103
Study First Received: February 24, 2012
Results First Received: June 25, 2013
Last Updated: June 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Galderma:
Healthy volunteers

Additional relevant MeSH terms:
Anesthetics
Tetracaine
Lidocaine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014